Computer systems validation quality (37 résultats)

Etat : New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.…

Etat : As New. Unread book in perfect condition.

Etat : New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.…

Etat : New.

Etat : As New. Unread book in perfect condition.

Etat : New.

Paperback / softback. Etat : New. New copy - Usually dispatched within 4 working days.

Etat : New. Brand New! Fast Delivery This is an International Edition and ship within 24-48 hours. Deliver by FedEx and Dhl, & Aramex, UPS, & USPS and we do accept APO and PO BOX Addresses. Order can be delivered worldwide within 6-10 days and we do have flat rate for up to 2LB. Extra shipping charges will be requested if the Book weight is more than 5 LB. This Item May be shipped from India, United states & United Kingdom. Depending on your location and availability.…

Hardcover. Etat : New. ISBN:9781498767361,Territorial restriction maybe printed on the book. This is an Int'l edition, ISBN and cover may differ from US edition, Contents same as US edition.

Paperback. Etat : Brand New. 2nd edition. 798 pages. 10.00x7.00x10.00 inches. In Stock.

Taschenbuch. Etat : Neu. Pharmaceutical Computer Systems Validation | Quality Assurance, Risk Management and Regulatory Compliance | Guy Wingate | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2024 | CRC Press | EAN 9781032917511 | Verantwortliche Person für die EU: Taylor & Francis Verlag GmbH, Kaufingerstr. 24, 80331 München, gpsr[at]taylorandfrancis[dot]com | Anbieter: preigu.…

Etat : As New. Unread book in perfect condition.

N.A. Etat : New. ISBN:9781498767361,Territorial restriction maybe printed on the book. This is an Int'l edition, ISBN and cover may differ from US edition, Contents same as US edition.

Hardcover. Etat : Brand New. 1st edition. 325 pages. 10.25x7.25x1.00 inches. In Stock.

Etat : As New. Unread book in perfect condition.

Etat : New.

Etat : New.

hardcover. Etat : Sehr gut. 798 Seiten; 9781420088946.2 Gewicht in Gramm: 500.

Etat : New.

Etat : New.

Etat : New.

Etat : New.

Etat : New.

Hardcover. Etat : Brand New. 3rd edition. 440 pages. 10.00x7.00x10.00 inches. In Stock.

Hardcover. Etat : Brand New. 2nd edition. 832 pages. 10.00x7.00x1.75 inches. In Stock.

Buch. Etat : Neu. Neuware - Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.Key Features - Covers governance framework, roles and responsibilities, quality culture, project life cycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and opportunities for performance improvement. - Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice. - Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs-complete with observations from inspections by the U.S. FDA and other regulators. - Discusses industry regulations and guidance, including current thinking of the U.S. FDA on computer software assurance, the latest guidance from the U.S. FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition). - Shares the practical experience and advice from a group of leading computer validation and compliance international experts.…

Etat : New.

Hardcover. Etat : New.

Etat : As New. Unread book in perfect condition.

Etat : As New. Unread book in perfect condition.